Phase 3 Clinical Study of AK112 for NSCLC Patients
A Randomized, Double-blind, Multi-center, Phase III Study of AK112 Combined With Pemetrexed and Carboplatin Versus Placebo Combined With Pemetrexed and Carboplatin in Patients With Locally Advanced or Metastatic EGFR-mutant Non-squamous NSCLC Who Have Failed Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs)
Sponsor: Akeso
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Progression-free survival (PFS)
Time frame: Up to 2 years
Secondary Endpoints
OS
ORR
DCR
Eligibility Criteria
Inclusion Criteria: 1. Ability to understand and voluntarily sign a written informed consent form (ICF), which must be signed before the specified study procedures required for the study are performed. 2. Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1. 4. Life expectancy ≥3 months； 5. Locally advanced (stage IIIB/IIIC) or metastatic (stage IV) non-squamous NSCLC confirmed by histology or cytology, inoperable and unable to receive radiotherapy and chemotherapy; 6. The tumor histology, cytology or hematology confirmed the presence of EGFR activating mutations before enrollment 7. Have previously received EGFR-TKI treatment and the treatment has failed 8. Subjects have at least one measurable non-brain tumor lesion per RECIST v1.1 9. Major organ function prior to treatment meets the following criteria 10. Patients of childbearing potential must agree to use effective contracepti…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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